SLND Versus Non-Dissection Following ESD for T1a Stage Esophageal Squamous Cell Carcinoma

NCT06979986 | Not Yet Recruiting DMC

• 1 other identifier: FJCHTOSP-1
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a study from Fujian Cancer Hospital Thoracic of Surgery Project, numbered as FJCHTOSP-1. Systematically mediastinal Lymph Node Dissection (SLD) Versus Non-Dissection Following Endoscopic Submucosal Dissection (ESD) for T1a Stage Esophageal Squamous Cell Carcinoma: a single-center, prospective clinical trial.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• DFS

  disease-free survival

  From enrollment to the end of treatment at 3 years

Study Arms (2)

Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection

EXPERIMENTAL

T1a Stage Esophageal Squamous Cell Carcinoma undergo Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection

Procedure: Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection

Endoscopic Submucosal Dissection without Systematically mediastinal Lymph Node Dissection

PLACEBO COMPARATOR

T1a Stage Esophageal Squamous Cell Carcinoma just recieve Endoscopic Submucosal Dissection treatment, not undergo Systematically mediastinal Lymph Node Dissection

Procedure: Endoscopic Submucosal Dissection without SLND

Interventions

Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection PROCEDURE

Participants will be evaluated for inclusion criteria and exclusion criteria, and then sign informal consent if desired. Participants will be randomly assigned to the intervention according to a prepared random tables. Participants in the SLND group will receive Endoscopic Submucosal Dissection with systematically mediastinal lymph node dissection

Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection

Endoscopic Submucosal Dissection without SLND PROCEDURE

Participants will be evaluated for inclusion criteria and exclusion criteria, and then sign informal consent if desired. Participants will be randomly assigned to the intervention according to a prepare random tables. Participants in the non-SLND group will just receive Endoscopic Submucosal Dissection treatment, not undergo Systematically mediastinal Lymph Node Dissection.

Endoscopic Submucosal Dissection without Systematically mediastinal Lymph Node Dissection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical stage T1aN0M0.
• A lesion detected on Endoscopic Ultrasound featured as T1a stage.
• Age 18 to 75.
• Patients who have signed the informed consent form.

You may not qualify if:

• Other than invasive adenocarcinoma by pathological analysis.
• Not complete resected or curative intent.
• Patients who have history of other malignant tumors.
• Patients who have history of thoracic surgery.
• Patients who have received radiation, chemotherapy or other treatments previously.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Related Publications (27)

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MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Weimin Fang

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruirong Lin, Ph.D

CONTACT

0591-62752788; lrr003@163.com

Jiarong Zhang, Ph.D

CONTACT

0591-62752789; lrrzgfj003@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 20, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share